Flecainide


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Ventricular arrhythmias 100 mg bid for 3-5 days, then reduce to lowest dose that controls arrhythmia. Max: 400 mg/day. Supraventricular arrhythmias 50 mg bid. Max: 300 mg/day. IV Rapid control of arrhythmias 2 mg/kg for 10-30 min. Max: 150 mg.
Dosage Details
Intravenous
Rapid control of arrhythmias
Adult: 2 mg/kg for 10-30 min. Max: 150 mg. For longer term parenteral therapy, start w/ 2 mg/kg over 30 min, continue w/ infusion at 1.5 mg/kg over the 1st hr and 100-250 mcg/kg/hr thereafter. Max total in the 1st 24 hr: 600 mg. Avoid infusing for >24 hr; shift to oral therapy as soon as possible.

Oral
Ventricular arrhythmias
Adult: Initially, 100 mg bid for 3-5 days, reduced to the lowest dose that controls the arrhythmia. Max: 400 mg daily.
Child: <6 mth Initially, 50 mg/m2 daily in divided doses; >6 mth Initially, 100 mg/m2 daily; Max: 200 mg/m2.
Elderly: Max initial dose: 100 mg daily.

Oral
Supraventricular arrhythmias
Adult: Initially, 50 mg bid. Max: 300 mg daily.
Child: <6 mth Initially, 50 mg/m2 daily in divided doses; >6 mth Initially, 100 mg/m2 daily; Max: 200 mg/m2.
Elderly: Max initial dose: 100 mg daily.
Special Patient Group
Oral:
Patients w/ permanent pacemaker; Patients receiving cimetidine or amiodarone: Max: 100 mg bid.
Renal Impairment
Oral
CrCl (mL/min) Dosage
 ≤35 Max initial dose: 100 mg daily. Dose may be adjusted after 6-7 days as tolerated.
Intravenous
CrCl (mL/min) Dosage
≤35
Reduce dose to 50%.
Hepatic Impairment
Oral:
Max: 100 mg daily.
Administration
May be taken with or without food.
Contraindications
Pre-existing 2nd- or 3rd-degree AV block w/o pacemaker, right bundle branch block associated w/ left hemiblock w/o pacemaker, cardiogenic shock, heart failure, history of MI, known Brugada syndrome.
Special Precautions
Patient w/ pacemakers, atrial fibrillation following cardiac surgery, atrial flutter, and structural heart disease. Renal (CrCl ≤35 mL/min) and significant hepatic impairment. Elderly. Childn. Pregnancy and lactation.
Adverse Reactions
Pro-arrhythmic effects, dizziness, visual disturbances, lightheadedness, giddiness, nausea, vomiting, headache, tremor, peripheral neuropathy, ataxia, paraesthesia, hypaesthesia, hyperhidrosis, syncope, tremor, vertigo, flushing, somnolence, tinnitus, increased sweating, depression, anxiety, insomnia, photosensitivity, and mild blood cells reduction. Rarely, hallucinations, amnesia, confusion, depression, dyskinesia, convulsion, urticaria, chest pain, elevated liver enzyme.
Potentially Fatal: Ventricular tachyarrhythmia, MI.
Patient Counseling Information
This drug may cause dizziness and visual disturbances, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor ECG, BP, plasma levels, and resp function.
Overdosage
Symptoms: Nausea and vomiting, convulsion, hypotension, bradycardia, widening of PR and QT intervals, ventricular tachycardia, AV nodal block, bundle branch block, asystole, cardiac and resp failures. Management: Symptomatic and supportive treatment. Inotropics (e.g. dopamine, dobutamine, isoproterenol), mechanical ventilation, and circulatory assistance (e.g. balloon pumping) may also be given.
Drug Interactions
Increased incidence of cardiac arrhythmias w/ other antiarrhythmics or arrhythmogenic drugs. Additive negative inotropic effects w/ Class II antiarrhythmics. Increased plasma conc w/ amiodarone, cimetidine quinidine, and ritonavir. Hypokalaemia may result w/ diuretics, corticosteroids, and laxatives.
Food Interaction
Decreased absorption w/ admin of milk.
Action
Description: Flecainide, an amide anaesthetic, belongs to Class Ic antiarrhythmic agents. It inhibits the transmembrane influx of extracellular Na ions via fast channels on cardiac tissues resulting to a decrease in rate of depolarisation of the action potential, prolonging the PR and QRS intervals. At high concentrations, it exerts inhibitory effects on slow Ca channels, accompanied by moderate negative inotropic effect.
Pharmacokinetics:
Absorption: Almost completely absorbed. Decreased absorption w/ milk. Bioavailability: Approx 90%. Time to peak plasma concentration: Approx 3 hr.
Distribution: Crosses the placenta and distributed in breast milk. Volume of distribution: 5.5 -8.7 L/kg (oral); approx 10 L/kg (IV). Plasma protein binding: Approx 40%.
Metabolism: Converted into m-O-dealkylated flecainide and m-O-dealkylated lactam of flecainide by CYP2D6 isoenzyme, subjected to genetic polymorphism.
Excretion: Via urine (30% as unchanged drug and the remainder as metabolites) and faeces (5%). Elimination half-life: Approx 20 hr.
Chemical Structure

Chemical Structure Image
Flecainide

Source: National Center for Biotechnology Information. PubChem Database. Flecainide, CID=3356, https://pubchem.ncbi.nlm.nih.gov/compound/Flecainide (accessed on Jan. 21, 2020)

Storage
Store between 20-25˚C.
MIMS Class
ATC Classification
C01BC04 - flecainide ; Belongs to class Ic antiarrhythmics.
References
Anon. Flecainide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 15/06/2016.

Buckingham R (ed). Flecainide Acetate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/06/2016.

Flecainide Acetate Tablet (Ranbaxy Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 15/06/2016.

Joint Formulary Committee. Flecainide Acetate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/06/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Flecainide Acetate. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 15/06/2016.

Disclaimer: This information is independently developed by MIMS based on Flecainide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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